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Rhabdomyolysis a result of azithromycin and statins: an unrecognized interaction

Johanna Strandell1, Andrew Bate, Staffan Hägg

  • 1The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. johanna.strandell@who-umc.org

British Journal of Clinical Pharmacology
|September 11, 2009
PubMed
Abstract

Insights

Reports suggest azithromycin and statin drug interactions may cause rhabdomyolysis. This analysis highlights the potential of the Omega measure for identifying adverse drug events in VigiBase.

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Clinical Pharmacology

Background:

  • The World Health Organization Adverse Drug Reaction database (VigiBase) is a global resource for monitoring drug safety.
  • A novel disproportionality measure, Omega, was developed to detect potential drug interactions.
  • Previous analyses identified a potential signal between azithromycin, statins, and rhabdomyolysis.

Purpose of the Study:

  • To investigate case reports of rhabdomyolysis associated with the co-administration of azithromycin and statins in VigiBase.
  • To assess the strength of evidence for a drug interaction between azithromycin and statins leading to rhabdomyolysis.

Main Methods:

  • Systematic review of individual case reports in VigiBase involving rhabdomyolysis, azithromycin, and statins.
  • Retrospective generation of Omega values to analyze reporting trends over time.
  • Exclusion of duplicate and follow-up reports to ensure data integrity.

Main Results:

  • Increased reporting of rhabdomyolysis with concomitant azithromycin and statin use was observed from 2000 onwards.
  • Fifty-three unique cases from five countries were identified.
  • Rhabdomyolysis onset occurred shortly after azithromycin initiation in 23% of cases, with reporters suggesting an interaction in 11 patients.

Conclusions:

  • Case reports in VigiBase suggest a potential interaction between azithromycin and statins, leading to rhabdomyolysis.
  • The Omega measure demonstrated utility in identifying potential drug interactions within VigiBase.
  • Spontaneous reporting systems can reveal previously unestablished drug interaction information.

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